2.4MM STERNALOCK (TM) SYSTEM 71-2643

GUDID 00841036072544

BIOMET MICROFIXATION, INC

Sternal fixation device
Primary Device ID00841036072544
NIH Device Record Keya06b4a05-acb1-41c8-97c6-9318272b515a
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.4MM STERNALOCK (TM) SYSTEM
Version Model Number71-2643
Catalog Number71-2643
Company DUNS046189866
Company NameBIOMET MICROFIXATION, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(904)741-4400
EmailFXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100841036072544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841036072544]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-11

On-Brand Devices [2.4MM STERNALOCK (TM) SYSTEM]

0084103607998775-6408
0084103607885075-6412
0084103607881275-6410
0084103607560671-6410
0084103607559071-6412
0084103607481471-6408
0084103607375675-2716
0084103607373275-2712
0084103607369575-2710
0084103607366475-2714
0084103607254471-2643
0084103607218675-2708
0084103607176971-2716
0084103607175271-2710
0084103607174571-2712
0084103607173871-2714
0084103606987271-2708

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